BLA submission

31 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Dbv Technologies

DBV Technologies' Peanut Allergy Patch Shows Strong Phase 3 Data Ahead of FDA Submission

DBV Technologies announced strong Phase 3 data for VIASKIN® Peanut patch, with 82.8% of treated children showing improved tolerance. FDA submission planned for H1 2026.
DBVTFDA approvalclinical trial results
GlobeNewswire Inc.GlobeNewswire Inc.··Dbv Technologies

DBV Technologies' Peanut Allergy Patch Shows Strong Phase 3 Data Ahead of FDA Submission

DBV Technologies' peanut allergy patch met Phase 3 goals with 46.6% responder rate versus 14.8% placebo, supporting planned 2026 FDA submission.
DBVTFDA approvalBLA submission
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

uniQure Class Action: Deadline Set for Lead Plaintiff Claims Over FDA Disclosure

uniQure faces class action lawsuit over failing to disclose FDA rejection of AMT-130 drug candidate, causing 49% stock decline. Lead plaintiff deadline: April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Legal Action Filed Against uniQure Over FDA Approval Statements

Class action lawsuit filed against uniQure for allegedly making false statements about FDA approval status and BLA submission timelines, misleading investors.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

uniQure Faces Class Action Over FDA Study Claims and BLA Timeline Disclosures

uniQure faces class action lawsuit alleging misleading statements about FDA study status and BLA timeline delays. Investors who purchased shares Sept-Oct 2025 may be eligible to claim.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kirby Mcinerney Llp

Class Action Lawsuit Alleges uniQure Withheld FDA Study Design Concerns

Class action lawsuit alleges uniQure withheld FDA study design concerns from investors, causing 49% stock decline after disclosure in November 2025.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Class Action Lawsuit Filed Against uniQure Over FDA Approval Disclosures

uniQure faces class action lawsuit alleging misleading FDA approval statements and understated BLA timeline risks. Investors who purchased securities between September-October 2025 may be eligible to participate.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

uniQure Faces Securities Lawsuit Over FDA Disclosure Gap; Lead Plaintiff Deadline Set

uniQure faces securities lawsuit over failing to disclose that FDA rejected its gene therapy candidate AMT-130, causing stock to plunge 49%. Lead plaintiff deadline set for April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

uniQure Stock Drops 49% Following FDA Rejection of AMT-130 Accelerated Approval

uniQure stock plummeted 49% after FDA rejected accelerated approval for gene therapy AMT-130, triggering a class action lawsuit alleging securities fraud.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Robbins Llp

uniQure Investors Face April Deadline in Securities Class Action Over FDA Disclosure Claims

Securities lawsuit against uniQure alleges misleading FDA disclosure statements about gene therapy candidate AMT-130. Stock fell 49% after November FDA feedback; investors must file claims by April 13, 2026.
QUREclass action lawsuitshareholder fraud
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

QURE Investors Face April Deadline in Securities Class Action Over AMT-130 Claims

uniQure faces securities lawsuit alleging misleading statements about AMT-130's FDA pathway. Stock dropped 49% after FDA reversed stance. Investors have April deadline for lead plaintiff claims.
QUREsecurities class actionmisleading statements